The TURN-OUT Trial: Transverse position. Using Rotation to aid Normal birth: OUTcomes following manual rotation.

Among women who are at least 37 weeks gestation, whose baby is in the occiput transverse position early in the second stage of labour, does manual rotation compared with a "sham" rotation, reduce the incidence of operative delivery? (Operative delivery is defined as forceps, ventouse or caesarean section).

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000005752

Acronym

POT-OUT: Persistent Occiput Transverse-OUTcomes following manual rotation

Enrollment

416

Registered

2013-01-04

Start date

2012-05-02

Completion date

2014-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In most labours, the baby is delivered head first, face downwards. When the baby is facing sideways (Occiput Transverse) or upwards (Occiput Posterior), the labour may be more difficult, and assisted deliveries including suction cup, forceps, and caesarean section are more likely. When the mother is fully dilated, it is possible to perform an internal examination and to physically rotate the baby to the downwards (anterior) position, but it is unknown if this procedure reduces the chances of an assisted delivery. We plan to run a study looking at whether performing a procedure to turn the baby will reduce the risk of assisted delivery and caesarean section.

Interventions

Manual rotation is a procedure that is most commonly performed at full dilatation if the fetal position is occiput posterior (OP) or occiput transverse (OT). It entails the use of the accoucheur's hand or fingers to rotate the fetal head from the OP and OT position to the usual OA position. The procedure takes 4-5 contractions to perform (about 6-10 mins).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

At least 37 completed weeks of gestation; Singleton pregnancy; Planning a vaginal delivery; Cephalic presentation; Full cervical dilatation; Fetus in the OP position confirmed by ultrasound. (OP position is defined as fetal occiput posterior with respect to the mother and within 45 degrees of the midline

Exclusion criteria

Clinical suspicion of cephalopelvic disproportion; previous caesarean section; brow or face presentation; “Pathologic” CTG according to RCOG classification plus either baseline >160 beats per minute or reduced variability for > 90 minutes; Fetal scalp pH < 7.25 or lactate > 4; Known major anatomical fetal abnormality (could influence safety or efficacy of manual rotation); Known or suspected chorioamnionitis; Intrapartum haemorrhage > 50mL; Temperature > 37.9 degrees C in the first stage of labour; Suspected fetal bleeding disorder; Pre-existing maternal diabetes

Outcome results